Postoperative SorethroatNCT03222700
The Recovery Profiles After Robotic or Open Thyroidectomy
An observational study of Postoperative Sorethroat and Postoperative Pain, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
In the present study, The investigators investigated the effect of surgical methods on the recovery of patients after robotic surgery and open thyroidectomy Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Postoperative Sorethroat, Postoperative Pain
- What is being tested?
- surgical procedure
- Type of treatment
- Surgery or procedure
- How many people
- 104 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2016to Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing robotic thyroidectomy or open conventional thyroidectomy
Who may be able to join
- Patients undergoing robotic thyroidectomy or open conventional thyroidectomy
- Adults 19 to 70 years of age
- American Society of Anesthesiologists Physical grade 1-2
Who cannot join
- Patients who underwent surgery on the neck and in the laryngeal area before
- Patients who do not understand or can not express pain scale
- Patients with sore throat and cough before surgery
- If intubation is difficult or repeated intubation is performed
- Patients who are using opioids or analgesics as chronic agents.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Ah-young Oh
Seongnam-si, Gyeonggi-do, 463-707
Yeji Lee, Pf, 82317877499, ladydaisy82@naver.com
About this study
In the present study, The investigators investigated the effect of surgical methods on the recovery of patients after robotic surgery and open thyroidectomy
- Conditions
- Postoperative Sorethroat, Postoperative Pain
- Being tested
- surgical procedure
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical procedureProcedure or surgery
In robotic thyroidectomy group, patients are received surgery using robotic system. In open thyroidectomy group, patients are received conventional open surgery.
| Study group | Role | What they receive |
|---|---|---|
| robotic thyroidectomy group | Not described Receives: Procedure: surgical procedure | |
| open thyroidectomy group | Not described Receives: Procedure: surgical procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative sore throat
none, mild, moderate, severe
Measured: postoperative 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start1 Sep 2016
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative SorethroatStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03222700
- Sponsor's protocol ID
- B-1606/351-005
- Status last verified
- Jul 2017
- First submitted
- 12 Jul 2017
- Last updated
- 19 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Recovery Profiles After Robotic or Open Thyroidectomy
- ClinicalTrials.gov ID
- NCT03222700
- Acronym / sponsor ID
- B-1606/351-005
- Conditions
- Postoperative Sorethroat, Postoperative Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 19 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the present study, The investigators investigated the effect of surgical methods on the recovery of patients after robotic surgery and open thyroidectomy
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| robotic thyroidectomy group | – | Procedure: surgical procedure |
| open thyroidectomy group | – | Procedure: surgical procedure |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing robotic thyroidectomy or open conventional thyroidectomy
Key inclusion criteria (3 listed)
- Patients undergoing robotic thyroidectomy or open conventional thyroidectomy
- Adults 19 to 70 years of age
- American Society of Anesthesiologists Physical grade 1-2
Key exclusion criteria (5 listed)
- Patients who underwent surgery on the neck and in the laryngeal area before
- Patients who do not understand or can not express pain scale
- Patients with sore throat and cough before surgery
- If intubation is difficult or repeated intubation is performed
- Patients who are using opioids or analgesics as chronic agents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgical procedureIn robotic thyroidectomy group, patients are received surgery using robotic system. In open thyroidectomy group, patients are received conventional open surgery. | Procedure or surgery | open thyroidectomy group, robotic thyroidectomy group |
Primary outcome
postoperative sore throat
Time frame: postoperative 1 hour
none, mild, moderate, severe
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Sorethroat and Postoperative Pain, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yeji Lee, Pf (82317877499, ladydaisy82@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative sore throat (time frame: postoperative 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2017.